1. Field of the Invention
The present invention relates generally to methods and apparatus for controlling bleeding from internal bodily organs, and/or manipulating the surface temperature or pressure thereof. More particularly, the present invention relates to method and apparatus carrying out hemostasis, retrieval of shedded blood, and other functions utilizing a device which surrounds the internal bodily organ.
In published reports by the National Center For Health Statistics, accidents including trauma, rank as leading cause of death in the age group 15-34 in the United States.
Trauma, blunt or penetrating, civilian or military, continues to be a major cause of bleeding and drainage of hospital and blood bank resources, with major loss of human life.
Solid abdominal organs are frequently injured by blunt and penetrating abdominal trauma. The peritoneal cavity does not provide adequate tamponade to stop bleeding from solid abdominal organs.
Several surgical techniques have been developed aiming at the control of bleeding from injured liver, spleen, kidney and other organs. These include suturing, resection and devascularization of the organ. A large number of liver, spleen and renal injuries do not respond to these techniques, leading to death of the patient or sacrifice of a valuable organ.
Major elective surgical procedures on the liver or other solid organs may also result in massive uncontrollable
contributing to the high morbidity and mortality bleeding, associated with these procedures.
Known techniques for control of major bleeding from the liver include:
(1) suture ligation;
(2) surgical or radiographic devascularization,;
(3) resection; and
(4) packing of the peritoneal cavity.
Inspite of the above-mentioned techniques, mortality from major liver injuries remain very high and is associated with high morbidity related to massive transfusions, hypothermia and coagulopathy which contributes to the drainage of health care resources.
In two articles published in the Journal of Trauma, Volume 26, No. 8, 1986, entitled "Liver Packing For Uncontrolled Hemorrhage: A Reappraisal", by R. Ivatury, et al., and "Packing For Control Of Hepatic Hemorrhage", by D. Feliciano, et al., packing for massive liver bleeding has been described as a last resort when all other hemostatic techniques fail. However, such a method of hemostasis has numerous shortcomings and drawbacks. For example:
(1) the anatomy of the liver and other solid abdominal organs does not yield itself to adequate compartmentalization utilizing packing techniques;
(2) extensive amount of packs are needed leading to an increase in intra-abdominal pressure, and consequently, compromising the patient's ventilation;
(3) this technique is incapable of adequately saving shedded blood for the purpose of autotransfusion;
(4) this technique does not allow for the manipulation or otherwise control of the pressure applied to the bleeding organ during a process of attempting to achieve tamponade; and
(5) the extensive foreign body effect relating to the liver packing of the peritoneal cavity leads to major septic complications.
Bleeding from the spleen, kidney, uterus and other organs can also lead to exsanguination. Several techniques have been applied to control bleeding from these organs. However, it is not infrequent that in desperation, sacrifice of the organ is undertaken to salvage the patient's life at a price of a major morbidity due to a loss of a valuable organ. In recent times, salvaging the spleen has become of major importance in the pediatric as well as the adult population since the medical community has learned more about the manifestations and consequences of post-splenectomy sepsis.
For the past two decades, attempts at splenic salvage have included:
(1) suturing techniques, which are occasionally successful;
(2) embolization of the splenic artery; and
(3) wrapping the spleen with omentum and/or absorbable mesh material in the aim of tamponading the bleeding and/or covering the row surface that is bleeding.
However, like packing, prior art spleen wrapping techniques do not allow for controllable manipulation of pressure on the organ, provide a liquid seal around the organ, or allow for the monitoring, collection, processing and reinfusion of shedded blood, among other things.
In a similar fashion, trauma to the kidney or internal bleeding from the uterus as due to post partum complications and other pathological processes, may lead to the sacrifice of the organ, after the application of alternative techniques fail.
Accordingly, in view of the shortcomings and drawbacks of prior art methods and apparatus for achieving hemostasis in massively bleeding organs, there clearly is a great need for new methodologies and apparatus which improve the salvage of human lives and are capable of achieving such a function while decreasing morbidity and preserving much needed human blood and other hospital resources.
Therefore, it is a primary object of the present invention to provide a method and apparatus for compartmentalizing an organ, and having the potential capability of applying controlled pressure to achieve control of the bleeding from an organ such as the liver, spleen, kidney, uterus and other organs.
It is a primary object to the present invention to provide a method and apparatus aimed at controlling and/or collecting the blood shedded from a solid organ, from whatever cause, but most commonly due to trauma or surgery, for the purpose of monitoring and autotransfusion.
It is another object of the present invention to provide a novel method of managing frequently fatal clinical situations, and is expected to result in a decrease in the amount of blood transfusions needed to stabilize a traumatized internal bodily organ, and thus contribute to saving lives.
Another object is to provide a method and apparatus for carrying out hemostasis of a hemorrhaging bodily organ in which the method is performed in an operating room and enables a traumatized patient to be rapidly stabilized prior to being moved to another institution, with less danger of uncontrolled hemorrhage.
A further object of the present invention is to provide apparatus for achieving hemostasis of a hemorrhaging intra-abdominal organ, without compromising other organ functions, such as respiration, or applying (i.e. transmitting) pressure to other intra-abdominal or thoracic organs.
A further object of the present invention is to provide apparatus which can be easily fabricated as a self-contained disposable unit.
Another object of the present invention is to provide apparatus capable of manipulating the organ surfacetemperature.
Yet an even further object of the present invention is to provide apparatus for compartmentalizing an internal bodily organ and being capable of achieving other functions, while being easy to apply and remove from the body.
Other and further objects of the present invention will be explained hereinafter, and will be more particularly delineated in the dependent claims and other objects of the present invention will be apparent to those with ordinary skill in the art to which the present invention pertains.